Colorectal CancerSaVeNCT05710809
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
A study testing Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement in people with Colorectal Cancer and Oncologic Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer, Oncologic Complications, Comprehensive Geriatric Assessment
- What is being tested?
- Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Feb 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or first line palliative chemotherapy for colorectal cancer
- ≥65 years of age at the time of signing the informed consent form
- Able to speak and read Danish, and to provide a signed informed consent form
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
Who cannot join
- Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
- Severe physical disability that hinders physical exercise
- Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
- Inability to sign informed content
- Patients who have had a consultation in the geriatric outpatient clinic within the past six months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jan Christensen, PhD contact
Denmark2 sites, 2 recruiting
- Not yet recruiting
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2400
Jan Christensen, PhD, 38633092, jan.christensen.02@regionh.dk
Katrine S Piper, PhD-Student
- Recruiting
Copenhagen University Hospital - Herlev and Gentofte Hospital
Herlev, 2730
Cecilia M Lund, PhD, +4538686112, Cecilia.Margareta.Lund.01@regionh.dk
Katrine S Piper, PhD-Student
About this study
The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy
Read the detailed description
Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.
- Conditions
- Colorectal Cancer, Oncologic Complications, Comprehensive Geriatric Assessment, Vestibular Rehabilitation, Geriatric Oncology, Sarcopenia
- Being tested
- Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia, Vertigo, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted specialized physical group-based exercise and Comprehensive Geriatric AssessementOther
Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions Receives: Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement |
| Usual care group | No intervention | Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index (DGI)
Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome
Measured: Three months
30 second Sit-to-Stand Test (30STS)
Between-group difference in lower limb muscle strength and endurance
Measured: Three months
Secondary outcomes (11)
Falls
Self-reported falls
Measured: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Hospital contacts due to falls
Hospital contacts due to falls
Measured: Baseline, three and six months
Balance disabilities/dizziness
Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome
Measured: Baseline, three and six months
Fear of falling
Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome
Measured: Baseline, three and six months
Health related quality of life
Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome
Measured: Baseline, three and six months
Peripheral nerve function
Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome
Measured: Baseline, three and six months
Autonomic function
Changes in autonomic function using Vagus device
Measured: Baseline, three and six months
Chemotherapy induced peripheral neuropathy
Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome
Measured: Baseline, three and six months
Muscle strength
Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms
Measured: Baseline, three and six months
Body composition
Changes in body composition using DXA
Measured: Baseline, three and six months
Muscle strength
Changes in muscle strength using handgrip test measuring weight in kilograms
Measured: Baseline, three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start20 Feb 2023
- Primary completion1 May 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital at Herlev, University Hospital Bispebjerg and Frederiksberg, Odense University Hospital, Department of Geriatric Medicine, Amager Hospital
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710809
- Sponsor's protocol ID
- H-22064206
- Acronym
- SaVe
- Status last verified
- Apr 2025
- First submitted
- 16 Jan 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On reasonable request
Publications
Piper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16.
PubMed 38631243
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05710809
- Acronym / sponsor ID
- SaVe / H-22064206
- Conditions
- Colorectal Cancer, Oncologic Complications, Comprehensive Geriatric Assessment, Vestibular Rehabilitation, Geriatric Oncology, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital - Rigshospitalet, Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital at Herlev, University Hospital Bispebjerg and Frederiksberg, Odense University Hospital, Department of Geriatric Medicine, Amager Hospital
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy
Detailed description
Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Targeted specialized physical group-based exercise and Comprehensive Geriatric AssessementPatients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions |
| Usual care group | No intervention | –Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Meet the criteria of the oncological departments of receiving neoadjuvant, adjuvant or first line palliative chemotherapy for colorectal cancer
- ≥65 years of age at the time of signing the informed consent form
- Able to speak and read Danish, and to provide a signed informed consent form
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
Key exclusion criteria (5 listed)
- Chemotherapy treatment within two years and sequelae of neuropathy, or symptoms of dizziness or vertigo, or balance disturbance
- Severe physical disability that hinders physical exercise
- Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial
- Inability to sign informed content
- Patients who have had a consultation in the geriatric outpatient clinic within the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted specialized physical group-based exercise and Comprehensive Geriatric AssessementVestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions | Other | Intervention group |
Primary outcome
Dynamic Gait Index (DGI)
Time frame: Three months
Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome
30 second Sit-to-Stand Test (30STS)
Time frame: Three months
Between-group difference in lower limb muscle strength and endurance
11 secondary outcomes
Falls
Time frame: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Hospital contacts due to falls
Time frame: Baseline, three and six months
Balance disabilities/dizziness
Time frame: Baseline, three and six months
Fear of falling
Time frame: Baseline, three and six months
Health related quality of life
Time frame: Baseline, three and six months
Peripheral nerve function
Time frame: Baseline, three and six months
Autonomic function
Time frame: Baseline, three and six months
Chemotherapy induced peripheral neuropathy
Time frame: Baseline, three and six months
Muscle strength
Time frame: Baseline, three and six months
Body composition
Time frame: Baseline, three and six months
Muscle strength
Time frame: Baseline, three and six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 38631243Piper KS, Suetta C, Schou JV, Ryg J, Andersen HE, Langevad LV, Evering D, Mikkelsen MK, Lund C, Christensen J. The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials. J Geriatr Oncol. 2024 May;15(4):101770. doi: 10.1016/j.jgo.2024.101770. Epub 2024 Apr 16.
- Individual participant dataSharing planned: Yes. On reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Christensen, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement in people with Colorectal Cancer and Oncologic Complications, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrine S Piper, PhD-Student (+4551156140, katrine.storm.piper@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (DGI) (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.